Episcissors-60 Reduces the Risk of Injuries

Episcissors-60 are simple to use surgical scissors, which guide an accurate mediolateral episiotomy at 60 degrees, thereby removing human error in estimating episiotomy angles during childbirth. There is evidence that this product is safer than letting women tear spontaneously in first normal births5

The angle of the cut is important, and the Royal College of Obstetricians and Gynaecologists (GTG29) recommends that cuts need to be at an angle of 60 degrees to reduce the incidence of poor patient outcomes, reconstructive surgery and litigation costs. Studies have shown that Episcissors-60 offer substantial NHS cost savings2, whilst potentially transforming outcomes for thousands of mothers each year4,5

Episcissors-60 are intended to be used by midwives or obstetricians trained in the mediolateral episiotomy technique, and can be used in secondary care midwifery and obstetric units, primary care midwifery units or birth centres, as well as during home births.

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After the introduction of Episcissors-60, we found that 86% of doctors and 100% of midwives were able to achieve post-suturing angles between 40 degrees and 60 degrees… user feedback showed high rates of satisfaction in using Episcissors-60 among all users.
Van Roon et al (2015), International Journal of Women’s Health
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Each year 30,000 women across the UK suffer obstetric anal sphincter injuries (OASIS). This is often due to misjudgement of the angle of surgical cuts during childbirth.

Episiotomy angle is a crucial factor in causation of OASIS. Sutured episiotomies angled too close to the midline (<30 degrees) or too far from the midline (>60 degrees) fail to unload the perineum sufficiently and predispose women to OASIS. OASIS is a serious complication and is the single most important cause of anal incontinence (AI) in women in the UK.

With over 15% of all births in England needing an episiotomy, there is a clear unmet clinical need to reduce incidences of OASIS and to protect mothers from avoidable harm, which can otherwise have a devastating impact on their lives.

The cost to the NHS of OASIS is approximately £57 million annually including repair (£1,625 per patient), elective caesarean sections and litigation (a recent High Court Judgement awarded £1.6 million to a single case of OASIS caused by an acutely angled episiotomy).

Developed by a team led by Professor Robert Freeman at Plymouth Hospitals NHS Trust, Episcissors-60 are adapted surgical scissors made from stainless steel with 5- centimetre long tungsten carbide cutting blades.  The device has a guide-limb angled at 60 degrees to the blades, mounted on the blade pivot point. During use, the guide limb is positioned by the clinician to be vertically in line with the perineal midline and pointing towards the anus to ensure an episiotomy cutting angle of 60 degrees. The guide limb is flexible to accommodate the head of the baby at crowning and maintain the cutting guide position. Two versions of the device are available, based upon operator preference:

  • A straight version with blades in line with the handles, designed to give an incision point directly at the posterior vaginal fourchette.
  • An angled version with blades at 150 degrees to the handles, designed to give an incision point horizontally offset by approximately 1 centimetre from the posterior vaginal fourchette.

Both versions of Episcissors-60 are designed for right-handed use: there is no left handed version available. The device can form part of a reusable equipment birthing pack, following standard device reprocessing procedures.

Medinvent supplies Episcissors-60 in the UK, and providers may purchase the product via the NHS Supply Chain website https://my.supplychain.nhs.uk/Catalogue/product/fcc454.

The innovator, Dharmesh Kapoor, Consultant Obstetrician and Gynaecologist at the Royal Bournemouth Hospital, was awarded NHS Innovation Accelerator Fellow status for Episcissors-60 in 2015.  Since that time, Dharmesh has focused upon:

  • Building the evidence base for Episcissors-60  by working with Croydon University Hospital
  • Raising awareness of OASIS (and Episcissors-60) through scientific learning events and exhibitions
  • Working with NHS England to secure an Innovation and Technology Tariff, operational from April 2017 (see below).
  • Partnering with the Department of Health (DH) so that Episcissors-60 are now available at a discount to the NHS on the NHS Supply Chain, with DH receiving royalties in international sales.

Episcissors-60 are the subject of a NICE medtech innovation briefing (MIB33), endorsed as the only CE marked device for guided episiotomy.

The Royal College of Obstetricians and Gynaecologists (RCOG) has also recognised the need to decrease the number of occurrences of OASIS and have developed a care bundle designed to standardise intrapartum perineal management. This includes the use of Episcissors-60 to reduce variation in the way that episiotomy is performed.  The development of this bundle is supported by the Health Foundation and by a collaboration between the RCOG, the Royal College of Midwives, the London School of Hygiene and Tropical Medicine, and the Croydon Health Services NHS Trust.

Approximately 15% of all births in England require an episiotomy. OASIS occur in 6.1% of first vaginal births in the UK (NICE MIB33).

In effectiveness trials, Episcissors-60 have been found to reduce the incidence of OASIS by 43% (range 20-50%), an absolute reduction in the OASIS rate from 5.6% to 3.2%.3  There are also intangible benefits from Episcissors-60, such as the promotion of safety culture and avoided costs from legal claims in some cases.

York Health Economics Consortium produced an economic impact analysis in August 2017, which found a return on investment for the NHS in Year 1 of 3,056%.2 This positive return on investment is a conservative estimate and will extend beyond the first year, providing Episcissors-60 continue to be used for episiotomies in subsequent years. It does not include the cost of usual episiotomy scissors, complications of OASIS, caesarean sections for subsequent births, the value of time off work for patients needing surgery or any costs from legal claims.

Also, the NHS Innovation Accelerator has developed an Impact Modelling Tool to provide an indication of the savings that could be achieved through implementation of Episcissors-60. This is included in the NHS England Episcissors-60 Toolkit (May 2017) – see Resources below.

This innovation aims to address maternal health, safety of care, and efficiency.

Episcissors-60 have been adopted by 50 NHS trusts1, including Liverpool Women’s NHS Foundation Trust; Wrightington, Wigan and Leigh NHS Foundation Trust; Norfolk and Norwich University Hospitals NHS Foundation Trust; the Royal Free London NHS Foundation Trust; University College London Hospitals NHS Foundation Trust; Frimley Health NHS Foundation Trust; University Hospitals Coventry and Warwickshire NHS Trust; Northampton General Hospital NHS Trust; and Chelsea and Westminster Hospital NHS Foundation Trust.

The AHSN for the North East and North Cumbria has supported an independent clinical assessment involving the following organisations:-

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • City Hospitals Sunderland NHS Foundation Trust
  • South Tees NHS Foundation Trust
  • North Cumbria University Hospitals NHS Trust, and
  • Northumbria Healthcare NHS Foundation Trust.

Support for the study and economic evaluation will be provided by Newcastle University, with the final report anticipated by December 2018. It is anticipated that the project will be an exemplar of network-wide collaboration, significantly reducing OASIS rates.

Of all the improvements in obstetrics in the past 20 years, this truly stands out for its simplicity and effectiveness.
Professor of Obstetrics, Dublin